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The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously. |
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| Cohort 2 | Experimental | During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
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| Cohort 3 | Experimental | During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
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| Cohort 4 | Experimental | During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously. |
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| Cohort 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCX168 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Up to 43 days | |
| Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters | Up to 29 days | |
| Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Up to 29 days | |
| Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters | Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of CCX168 | Period 1: Up to Day 8; Period 2: Up to Day 15 | |
| Time of Cmax of CCX168 | Period 1: Up to Day 8; Period 2: Up to Day 15 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) AG | Allschwil | CH-4123 | Switzerland |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D008180 | Lupus Erythematosus, Systemic |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000620232 | avacopan |
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During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously. |
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| Placebo | Drug | Administered orally. |
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| Terminal Phase Rate Constant of CCX168 |
| Period 1: Up to Day 8; Period 2: Up to Day 15 |
| Apparent Terminal Half-life of CCX168 | Period 1: Up to Day 8; Period 2: Up to Day 15 |
| Apparent Oral Clearance of CCX168 | Period 1: Up to Day 8; Period 2: Up to Day 15 |
| Apparent Volume of Distribution of CCX168 | Period 1: Up to Day 8; Period 2: Up to Day 15 |
| Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t | Period 1: Up to Day 8; Period 2: Up to Day 15 |
| AUC of CCX168 From Time 0 to Infinity | Period 1: Up to Day 8; Period 2: Up to Day 15 |
| AUC of CCX168 From Time 0 to 24 Hours | Periods 1 and 2: Up to Hour 24 |
| AUC of CCX168 From Time 0 to 12 Hours | Periods 1 and 2: Up to Hour 12 |
| AUC of CCX168 From Time 12 to 24 Hours | Periods 1 and 2: Hour 12 to Hour 24 |
| Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval | Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12 |
| Period 2: Accumulation Ratio of CCX168 | Up to Day 7 |
| Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils | Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7 |